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Actinic Keratosis

55
Pipeline Programs
16
Companies
50
Clinical Trials
1
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
11
5
13
0
20
6
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Small Molecule
1100%
+ 66 programs with unclassified modality

On Market (1)

Approved therapies currently available

Almirall
KLISYRIApproved
tirbanibulin
Almirall
Microtubule Inhibitor [EPC]topical2020
3M Part D

Competitive Landscape

16 companies ranked by most advanced pipeline stage

Leo Pharma
Leo PharmaDenmark - Ballerup
35 programs
9
5
3
9
2
Inggenol Mebutate 0.015%Phase 41 trial
ingenol mebutate gel 0.015%Phase 41 trial
CryotherapyPhase 31 trial
Ingenol MebutatePhase 31 trial
Ingenol mebutate gel 0.05 %Phase 31 trial
+30 more programs
Active Trials
NCT03508856Completed23Est. Aug 2016
NCT02090465Completed840Est. Dec 2013
NCT02362152Completed1,168Est. Dec 2015
+32 more trials
Galderma
GaldermaTX - Dallas
7 programs
1
4
1
Metvix PDTPhase 41 trial
MethylaminolevulinatePhase 31 trial
Metvix-PDTPhase 31 trial
Photodynamic therapy with Metvix 160 mg/g creamPhase 31 trial
Photodynamic therapy with methyl aminolevulinate creamPhase 31 trial
+2 more programs
Active Trials
NCT02674048Completed406Est. Nov 2016
NCT03006185Completed18Est. Mar 2017
NCT00926952Completed20Est. Jan 2011
+4 more trials
Almirall
AlmirallSpain - Barcelona
5 programs
4
1
KLISYRI(tirbanibulin)Phase 45 trials
5-fluorouracil/salicylic acidPhase 31 trial
KX2-391Phase 33 trials
LAS41005Phase 32 trials
LAS41007Phase 32 trials
Active Trials
NCT02289768Completed166Est. Sep 2015
NCT03285477Completed351Est. Apr 2019
NCT03285490Completed351Est. Apr 2019
+10 more trials
Fitzpatrick Company
Fitzpatrick CompanyON - Waterloo
1 program
1
Inggenol Mebutate 0.015%Phase 4
Biofrontera
BiofronteraGermany - Leverkusen
6 programs
1
2
3
BF-200 ALAPhase 31 trial
BF-200 ALA gelPhase 31 trial
VehiclePhase 31 trial
BF-200 ALA 1%Phase 21 trial
Topical aminolevulinatePhase 21 trial
+1 more programs
Active Trials
NCT05060237Completed112Est. Apr 2023
NCT02799030Completed105Est. Mar 2007
NCT06027619Completed30Est. Jul 2024
+3 more trials
Bausch Health
Bausch HealthQUEBEC, Quebec, Canada
2 programs
2
clindamycin phosphate/benzoyl peroxidePhase 2
lidamycin phosphate and benzoyl peroxide 1.2%/3.75% combinationPhase 21 trial
Active Trials
NCT03122457Completed22Est. Jul 2018
Vidac Pharma
Vidac PharmaIsrael - Ness Ziona
1 program
1
10% VDA-1102Phase 21 trial
Active Trials
NCT03538951Completed83Est. Dec 2018
Torqur
TorqurSwitzerland - Basel
1 program
1
BimiralisibPhase 2Small Molecule1 trial
Active Trials
NCT06319794Completed46Est. Jun 2025
Maruho
MaruhoJapan - Osaka
1 program
1
ICVT Topical GelPhase 21 trial
Active Trials
NCT03684772Unknown32Est. Sep 2019
Moberg Pharma
Moberg PharmaSweden - Stockholm
1 program
1
ImiquimodPhase 21 trial
Active Trials
NCT01611480Completed
Sandoz
SandozAustria - Kundl
1 program
1
Investigational TreatmentPhase 21 trial
Active Trials
NCT02404389Completed82Est. Jan 2016
Genzada Pharmaceuticals
1 program
1
GZ21TPhase 11 trial
Active Trials
NCT06888362Completed41Est. Mar 2025
Teva
TevaIsrael - Petach Tikva
2 programs
Diclofenac sodiumPHASE_31 trial
Imiquimod Cream, 3.75%PHASE_31 trial
Active Trials
NCT02611804Completed492Est. Aug 2016
NCT01686152Completed589Est. Aug 2013
Parexel
ParexelMA - Boston
1 program
MetvixN/A
Biotest Pharmaceuticals
Biotest PharmaceuticalsGermany - Dreieich
1 program
SOR007PHASE_21 trial
Active Trials
NCT03083470Completed33Est. Mar 2018
PharmaEssentia
PharmaEssentiaMA - Burlington
1 program
KX01 ointment 1%PHASE_31 trial
Active Trials
NCT05231044Completed108Est. Nov 2023

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
Almiralltirbanibulin
Almiralltirbanibulin
Almiralltirbanibulin
Leo Pharmaingenol mebutate gel 0.015%
Leo PharmaInggenol Mebutate 0.015%
GaldermaMetvix PDT
Almiralltirbanibulin
Almiralltirbanibulin
Almiralltirbanibulin
PharmaEssentiaKX01 ointment 1%
AlmirallKX2-391
AlmirallKX2-391
Leo Pharmaingenol disoxate gel 0.018%
Leo PharmaLEO 43204 gel
Leo PharmaLEO 43204 gel

Showing 15 of 49 trials with date data

Clinical Trials (50)

Total enrollment: 11,228 patients across 50 trials

Tirbanibulin 1% Ointment for the Treatment of Actinic Keratosis on the Back of the Hands

Start: Oct 2023Est. completion: Dec 20240
Phase 4Withdrawn

A Study of Tirbanibulin on the Wellbeing of Participants With Actinic Keratoses

Start: Jan 2023Est. completion: Jan 2024334 patients
Phase 4Completed

A Study of Tirbanibulin Ointment and Diclofenac Sodium Gel for the Treatment of Adult Participants With Actinic Keratosis on the Face or Scalp

Start: Oct 2022Est. completion: Jul 2027447 patients
Phase 4Active Not Recruiting
NCT02716714Leo Pharmaingenol mebutate gel 0.015%

Clinical Trial of Ingenol Mebutate Gel 0.015% & 0.05% in Actinic Keratosis

Start: Apr 2015Est. completion: Jun 201677 patients
Phase 4Completed
NCT02446223Leo PharmaInggenol Mebutate 0.015%

Evaluate the Efficacy and Safety of Large-Scale Field-Directed Topical Therapy of Actinic Keratosis of the Chest w/Ingenol Mebutate 0.015%

Start: Jan 2015Est. completion: Sep 201621 patients
Phase 4Completed

Gene Expression in Renal Transplant Patients With Field Actinic Keratosis Undergoing Metvix® Photodynamic Therapy (PDT)

Start: Oct 2009Est. completion: Oct 20119 patients
Phase 4Completed

Efficacy and Safety of Cryotherapy Followed by Tirbanibulin Ointment for Actinic Keratosis on the Scalp and Forehead

Start: Nov 2025Est. completion: Nov 202759 patients
Phase 3Not Yet Recruiting

A Study to Evaluate the Efficacy and Safety of Tirbanibulin Ointment in Adult Participants With Actinic Keratosis

Start: Dec 2023Est. completion: Nov 2025280 patients
Phase 3Completed

A Study to Evaluate the Safety and Tolerability of Tirbanibulin Ointment 1% in Adult Participants With Actinic Keratosis

Start: Jun 2022Est. completion: Dec 2022105 patients
Phase 3Completed

A Multi-Center Study to Evaluate the Efficacy and Safety of KX01 Ointment 1% on Actinic Keratosis on Face or Scalp

Start: Dec 2021Est. completion: Nov 2023108 patients
Phase 3Completed

A Multi-Center Study to Evaluate the Efficacy and Safety of KX2-391 Ointment 1% on AK on Face or Scalp

Start: Sep 2017Est. completion: Apr 2019351 patients
Phase 3Completed

A Multi-Center Study to Evaluate the Efficacy and Safety of KX2-391 Ointment 1% on Actinic Keratosis on Face or Scalp (AK004)

Start: Sep 2017Est. completion: Apr 2019351 patients
Phase 3Completed
NCT03115476Leo Pharmaingenol disoxate gel 0.018%

A Trial to Compare the Incidence of Squamous Cell Carcinoma (SCC) and Other Skin Neoplasia on Skin Areas Treated With Ingenol Disoxate Gel or Vehicle Gel for Actinic Keratosis on Face and Chest or Scalp

Start: Jun 2017Est. completion: Mar 2018563 patients
Phase 3Terminated

Efficacy and Safety of LEO 43204 in the Field Treatment of Actinic Keratosis on Face or Chest including12-month Follow-up

Start: Nov 2015Est. completion: Aug 2017383 patients
Phase 3Completed

Efficacy and Safety of LEO 43204 in Field Treatment of Actinic Keratosis on Face or Chest Including 12-month Follow-up

Start: Nov 2015Est. completion: Nov 2017437 patients
Phase 3Completed

Efficacy and Safety of LEO 43204 in Field Treatment of Actinic Keratosis on Balding Scalp Including 12-month Follow-up

Start: Nov 2015Est. completion: Aug 2017373 patients
Phase 3Completed

Efficacy and Safety of LEO 43204 in Field Treatment of Actinic Keratosis on Balding Scalp Including 12-month Follow-up

Start: Nov 2015Est. completion: Aug 2017391 patients
Phase 3Completed
NCT02611804TevaDiclofenac sodium

A Randomized, Double-Blind, Parallel-Group, Vehicle-Controlled, Multicenter Study Comparing Diclofenac Sodium Gel, 3% to Solaraze® Gel, 3% in the Treatment of Actinic Keratosis on the Face or Bald Scalp

Start: Oct 2015Est. completion: Aug 2016492 patients
Phase 3Completed
NCT02361216Leo PharmaIngenol Mebutate

Efficacy and Safety of Ingenol Mebutate Gel for Actinic Keratosis Applied on Large Area on Face, Scalp or Chest

Start: Apr 2015Est. completion: Mar 2017729 patients
Phase 3Completed
NCT02289768Almirall5-fluorouracil/salicylic acid

Study To Evaluate The Efficacy And Safety Of Actikerall® Solution In Patients With Grade I-II Actinic Keratoses

Start: Oct 2014Est. completion: Sep 2015166 patients
Phase 3Completed

Safety and Efficacy Study for the Field-directed Treatment of Actinic Keratosis (AK) With Photodynamic Therapy (PDT)

Start: Oct 2013Est. completion: Apr 201587 patients
Phase 3Completed
NCT01787383Leo PharmaIngenol mebutate gel 0.05 %

A Simultaneous Treatment Regimen Compared to a Sequential Treatment Regimen With Ingenol Mebutate Gel 0.015% and 0.05% of Two Areas With Actinic Keratosis on Face/Scalp and Trunk/Extremities

Start: Feb 2013Est. completion: Jan 2014200 patients
Phase 3Completed
NCT01686152TevaImiquimod Cream, 3.75%

Study Comparing Imiquimod Cream, 3.75% to Zyclara® (Imiquimod) Cream, 3.75% in the Treatment of Actinic Keratosis

Start: Sep 2012Est. completion: Aug 2013589 patients
Phase 3Completed
NCT01600014Leo PharmaIngenol mebutate gel, 0.015%

Ingenol Mebutate Gel, 0.015% Repeat Use for Multiple Actinic Keratoses on Face and Scalp

Start: May 2012Est. completion: Feb 2014463 patients
Phase 3Completed

A Sequential Treatment Regimen of Cryotherapy and Picato® for the Treatment of Actinic Keratosis on the Face and Scalp

Start: Mar 2012Est. completion: Jul 2013367 patients
Phase 3Completed

Double-blind, Randomized, Vehicle- and Comparator-controlled, Multi-center Trial to Evaluate the Efficacy and Safety of LAS41007 in the Treatment of Actinic Keratosis

Start: Nov 2010Est. completion: Mar 2012889 patients
Phase 3Completed
NCT00926952GaldermaMethylaminolevulinate

Short Incubation Methylaminolevulinate Photodynamic Therapy Without Occlusion

Start: Jul 2009Est. completion: Jan 201120 patients
Phase 3Completed

Study on the Efficacy of LAS41005 in the Treatment of Actinic Keratosis

Start: Jun 2008Est. completion: Jun 2009470 patients
Phase 3Completed

Evaluation of Safety and Efficacy of BF-200 ALA for the Treatment of Actinic Keratosis With Photodynamic Therapy

Start: Apr 2008Est. completion: Aug 2009571 patients
Phase 3Completed

Evaluation of Efficacy and Safety of BF-200 ALA Used With Photodynamic Therapy in Patients With Actinic Keratosis.

Start: Dec 2007Est. completion: Oct 2008122 patients
Phase 3Completed
NCT00306800GaldermaPhotodynamic therapy with methyl aminolevulinate cream

Metvix PDT Versus Vehicle PDT With Aktilite CL128 Lamp in Patients With Actinic Keratosis on the Face and Scalp

Start: Sep 2007Est. completion: Oct 200780 patients
Phase 3Completed

Metvix PDT Versus Vehicle PDT With Aktilite CL128 Lamp in Patients With Actinic Keratosis on the Face and Scalp

Start: Mar 2006Est. completion: Jan 2007131 patients
Phase 3Completed
NCT00472459GaldermaPhotodynamic therapy with Metvix 160 mg/g cream

Photodynamic Therapy (PDT) With Metvix® 160 Milligrams/Gram Cream in Organ Transplant Participants With Non-melanoma Skin Cancer

Start: Jul 2003Est. completion: Jul 200682 patients
Phase 3Completed

Efficacy and Safety of a New Topical Formulation With Imiquimod (Limtop) Applied 1, 3 or 7 Times Weekly During 2 x 2 Weeks Treatment for Actinic Keratosis on the Head

Phase 2Completed

Study on the Safety and Efficacy of Bimiralisib Gel in Participants Suffering From Actinic Keratosis

Start: Apr 2024Est. completion: Jun 202546 patients
Phase 2Completed
NCT06027619BiofronteraTopical aminolevulinate

Short Contact Protocols to Reduce Pain During 10% ALA Gel Red-light Photodynamic Therapy of Actinic Keratoses

Start: Oct 2023Est. completion: Jul 202430 patients
Phase 2Completed
NCT03684772MaruhoICVT Topical Gel

Topical Ionic Contra-Viral Therapy in Actinic Keratosis

Start: Oct 2018Est. completion: Sep 201932 patients
Phase 2Unknown

Study to Evaluate the Efficacy, Safety, and Tolerability of Topical VDA-1102 Ointment in Subjects With Actinic Keratosis

Start: May 2018Est. completion: Dec 201883 patients
Phase 2Completed

Study of SOR007 Ointment for Actinic Keratosis

Start: May 2017Est. completion: Mar 201833 patients
Phase 2Completed
NCT03122457Bausch Healthlidamycin phosphate and benzoyl peroxide 1.2%/3.75% combination

Perimenstrual Acne With Clindamycin Phosphate and Benzoyl Peroxide

Start: Jan 2017Est. completion: Jul 201822 patients
Phase 2Completed
NCT03006185GaldermaAblative Fractional Carbon Dioxide

Laser and Microdermabrasion Before Photodynamic Therapy for Actinic Keratoses in Field-cancerized Skin

Start: Aug 2016Est. completion: Mar 201718 patients
Phase 2Completed

Activity & Safety Study of KX2-391 Ointment in Participants With Actinic Keratosis on the Face or Scalp

Start: Apr 2016Est. completion: Dec 2017168 patients
Phase 2Completed
NCT02404389SandozInvestigational Treatment

Safety, Tolerability, and Efficacy Study of LFX453 in Actinic Keratosis Patients

Start: Mar 2015Est. completion: Jan 201682 patients
Phase 2Completed

Safety of LEO 43204 for Actinic Keratosis Applied on Face/Chest, Scalp and Trunk/Extremities, Respectively

Start: Mar 2015Est. completion: Aug 2015189 patients
Phase 2Completed
NCT02354391Leo PharmaIngenol mebutate Picato® and MAL PDT day 1, day 5

Ingenol Mebutate (Picato®) With Methyl Aminolevulinate Photodynamic Therapy for the Treatment of Actinic Keratosis

Start: Jan 2015Est. completion: Dec 201920 patients
Phase 2Unknown
NCT01998984Leo Pharmaingenol mebutate

Efficacy and Safety of Ingenol Mebutate Gel 0.06% When Applied Once Daily for 2, 3 or 4 Consecutive Days to a Treatment Area of Approximately 250 cm2 on Trunk and Extremities in Subjects With Actinic Keratosis

Start: Jan 2014Est. completion: Jul 2014266 patients
Phase 2Completed

LAS41005 in Hyperkeratotic Actinic Keratosis

Start: Apr 2011Est. completion: Aug 201267 patients
Phase 2Completed

Efficacy and Safety Study of LAS41007 in the Treatment of Actinic Keratosis

Start: Aug 2009Est. completion: Feb 2010100 patients
Phase 2Completed

A Clinical Trial of Topical Photodynamic Therapy With 5-aminolevulinic Acid for the Treatment of Actinic Keratosis

Start: Oct 2006Est. completion: Mar 2007105 patients
Phase 2Completed

Safety and Efficacy of Doses of LEO 43204 Once Daily for Two Consecutive Days on Full Balding Scalp in Subjects With Actinic Keratosis

Start: May 2014Est. completion: Mar 2015220 patients
Phase 1/2Completed

Phase Legend

PreclinicalLab & animal studies
Phase 1Safety & dosing
Phase 2Efficacy testing
Phase 3Large-scale trials
On MarketApproved & available

Key Insights

20 late-stage (Phase 3) programs, potential near-term approvals
16 companies competing in this space

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.